In a conventional two-piece ostomy appliance, the plastic coupling rings of a pouch and faceplate form the dual functions of mechanically securing the parts together and forming a fluid-tight seal to prevent the escape of exudate and gases The second of these functions, in particular, requires that the mating rings be precisely matched, and that they not be scratched, deformed, or otherwise damaged in handling, if problems of leakage are to be avoided. Even when care is taken to avoid such damage and security is achieved, the needs of ostomates may not be completely met by current products That is often the case even where the faceplates of current two-piece products are used with protective skin barrier rings that sealingly contact the peristomal skin surfaces and are intended to prevent leakage and protect the skin from the excoriating effects of exudate contact.
Some two-piece appliances are objectionable because they are not low enough in "profile" to allow concealment of their use beneath a patient's clothing. Others fail to provide sufficient tactile feedback to signal the user when a fluid-tight seal has been formed. Another typical problem is that the close proximity of the faceplate's skin barrier ring to the stoma makes cleaning of the peristomal area difficult when the pouch is removed and the stoma is exposed. Furthermore, skin barrier materials of ostomy appliances are ordinarily of compromise or all-purpose formulations expected to be used with stomas located at any of a variety of sites such as the ileum, the descending colon, or the ureter, even though such a composition may not be ideally formulated for the particular location involved. What is needed is an appliance skin barrier that is matched to the solubility characteristics of the exudate from a specific location for a given patient, thereby minimizing barrier erosion and enabling predictable weartime.
Accordingly, it is an object of this invention to provide a two-piece ostomy appliance that overcomes the aforementioned shortcomings of existing appliances. Specifically, the appliance of this invention utilizes coupling rings that perform only a mechanical latching function, not a sealing function, and therefore need not be precisely formed and matched to provide a liquid-tight seal. Slight surface imperfections in the coupling rings occurring during manufacture or use do not compromise the sealing effectiveness of the appliance because the rings are needed only to provide a secure mechanical interconnection.
Since the pouch's barrier ring is held in place against the wearer's skin by the mechanical latching between the coupling rings and the surrounding adhesive attachment of the faceplate to the patient, a sealant composition of reduced tack, or even no tack, may be used, thereby reducing one cause of skin stripping and irritation. Also, since the barrier ring is mounted upon the pouch rather than the faceplate, the arrangement allows multiple barrier compositions to be used with the same faceplate, thereby matching the right barrier to a specific user need. Such matching minimizes barrier erosion and makes weartime more predictable than with conventional appliances.
Since the barrier is provided as part of the pouch subassembly, removal of the pouch results in exposure of a substantial peristomal area even though the faceplate remains in place. Such an arrangement makes cleaning of the site easier and more effective. The arrangement also lends itself to having a lower profile than existing systems, thereby increasing the likelihood that the user's medical condition will not be unintentionally disclosed by unsightly bulges in clothing. The assembly tends to produce an audible and tactile click when latched so that attachment to the skin of the pouch barrier ring may be tactily perceived, thereby enhancing the perceived security of the device.
Briefly, the appliance takes the form of a collection pouch with a flexible plastic first coupling ring secured to its side wall about an opening formed therein, and a faceplate having a second coupling ring of flexible plastic adapted to latch with the first coupling ring of the pouch. The faceplate includes annular adhesive attaching means extending radially outwardly from the second coupling ring for adhesively engaging a wearer's skin.
A particularly important feature is the provision of a pouch barrier ring of soft, deformable, skin-contacting sealant material, preferably an adhesive material having both wet and dry tack, secured to the first coupling ring, that is, the pouch coupling ring. The pouch barrier ring extends inwardly from that coupling ring and has an outside diameter smaller than the opening of the adhesive attachment means of the faceplate. Therefore, the pouch barrier ring makes sealing contact with peristomal skin surfaces within the area circumscribed by both coupling rings and by the adhesive attachment means of the faceplate, when the appliance is worn.
Other features, advantages, and objects will be appear from the specification and drawings.